NCT04241029Completed
Boosting Biologics in UC
Boosting Biologics in Ulcerative Colitis
Source: ClinicalTrials.gov · Last updated 6 May 2024
Brief summary (registry, in English)
This study evaluates the safety of the probiotic compound IDOFORM TRAVEL® in patients with ulcerative colitis undergoing anti-TNF treatment with insufficient clinical response. Furthermore, the study aims to explore the composition of the bacteria of the gut as well as the immunological activity in patients with ulcerative colitis undergoing anti-TNF treatment, aiming to identify differences between groups of patients responding and not responding adequately to treatment. The project will explore whether probiotics have beneficial effects as adjuvant therapy in ulcerative colitis patients with insufficient response to anti-TNF treatment.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 17 Jan 2020
- Start date
- 25 Feb 2020
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- Oslo University Hospital
- Diseases
- Ulcerative colitis
- NCT number
- NCT04241029
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From 25 Feb 2020 to the primary completion date, 15 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous use of anti-TNF medication
- Concomitant use of non-steroid anti-inflammatory drugs (NSAIDS) or corticosteroids
- Concomitant use of antithrombotic pharmaceutical substances
- Regular (weekly) use of any probiotic substance within 3 months prior to inclusion
- Use of antibiotics within 3 months prior to inclusion
Other illness
- History of bowel resection, other inflammatory bowel disease (IBD)-related surgery, or other major intestinal surgery
- Plasma hepatitis C (HCV) positive
- HIV positive
- Comorbidity of coeliac disease or malnutrition
- Heart failure (NYHA class II-IV)
Lab values
- Signs of severe ulcerative colitis as defined by the "Montreal classification of severity of ulcerative colitis" = 3: Passage of at least six bloody stools daily, pulse rate of at least 90 beats per minute, temperature of at least 37.5°C, haemoglobin of less than 10.5 g/100 ml, and erythrocyte sedimentation rate (ESR) of at least 30 mm/h.
- Serum hepatitis B surface antigen (HBsAg) positive
- Deranged liver function (serum albumin \< 25 g/L or Child-Pugh ≥10)
- Renal failure (estimated glomerular filtration rate (eGFR) \< 30
Other
- Clinical status poor to such extent that treating physician finds refraining from escalation of treatment contraindicated
- Pregnancy
- Any reason why, in the opinion of the investigator, the patient should not participate
Who the study is looking for
- Subjects may be included as cases in the study if they meet all of the following criteria:
- Diagnosed With ulcerative colitis based on Lennard-Jones criteria
- Under treatment With anti-TNF infusions/injections defined as infliximab or adalimumab
- Failure to Reach remission upon routine evaluation colonoscopy after 6-12 months of treatment - defined as an endoscopy sub score of ≥ using the Mayo score for ulcerative colitis
- Age 18-75
- Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
- Subjects may be included as Control subjects in the sub-study if they meet all of the following criteria:
- Diagnosed With ulcerative colitis based on Lennard-Jones Criteria
- Under treatment With anti-TNF infusions/injections defined as infliximab or adalimumab
- Remission upon routine colonoscopy after 6-12 months of treatment - defined as an endoscopy sub score of ≤ using the Mayo score for ulcerative colitis
- Age 18-75
- Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
- OR if they meet all the following criteria:
- No history of inflammatory bowel disease
- Age 18-75
- Signed informed consent and expected Cooperation of the patients for the treatment and follow up must be obtained and documented according to International Committee on Harmonization (ICH) Good Clinical Practice (GCP), and national/local regulations.
Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Oslo University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.